MAUDE Adverse Event Report: SYNTHES GMBH UNK - FACET WEDGES; ORTHOSIS,PEDICLE,SPINAL FIXATION

Catalog Number UNK - FACET WEDGES

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Muscular Rigidity (1968); Nerve Damage (1979)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown facet wedge/unknown lot.Part and lot numbers are unknown; udi number is unknown.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) for patients undergoing spinal decompression/fusion.Failed spinal decompression/fusion has been identified as the reported complication as per spine tango registry report experienced by the following with corresponding intervention: 1 patient had general complications - postoperative surgical before discharge: cardiovascular (1).2 patients had surgical complications - intraoperative adverse events: dural lesion (2).4 patients had surgical complications - postoperative surgical before discharge: radiculopathy (1), motor dysfunction (1), bowel/bladder dysfunction (1), implant malposition (1).This is for depuy synthes facet wedges.This is report 2 of 2 for (b)(4).

• Brand Name: UNK - FACET WEDGES
• Type of Device: ORTHOSIS,PEDICLE,SPINAL FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: dan nelson ; 375 river park circle; marquette, MI 49855
• MDR Report Key: 11821058
• MDR Text Key: 265280964
• Report Number: 8030965-2021-03910
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK - FACET WEDGES
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/30/2021
• Initial Date FDA Received: 05/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention